Implantable Miniature Telescope™ - P050034
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Implantable Miniature Telescope™ (by: Dr. Isaac Lipshitz).
PMA Applicant: VisionCare Ophthalmic Technologies
Address: 14395 Saratoga Avenue #150, Saratoga, California 95070
Approval Date: July 1, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050034a.pdf
What is it? The VisionCare Ophthalmic Technologies Implantable Miniature Telescope TM (IMT) is a system to magnify objects to improve vision in patients with end-stage, age-related macular degeneration (AMD). The IMT is surgically implanted in one eye only and is available in two models. One with 2.2 times magnification and the other with 2.7 times magnification.
How does it work? The IMT magnifies images and projects them onto a part of the retina that is healthy and can still see images. It does not cure macular degeneration.
When is it used? The IMT is intended to improve vision in patients 75 years of age or older with stable, severe to profound vision impairment caused by end-stage age-related macular degeneration. It is indicated for patients with geographic atrophy or disciform scarring of the fovea, a visually significant cataract, and who achieve at least a 5-letter improvement on the visual acuity chart using a trial external telescope.
What will it accomplish? The IMT may improve distance and near vision in people who have lost central vision because of end-stage AMD.
Additional information: Summary of Safety and Effectiveness and labeling are available online.